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Senior Clinical Trial Manager (CTM)

Role overview

Qualifications

  • Bachelorโ€™s degree in a scientific field; advanced scientific degree preferred
  • 5+ years directly managing clinical trials in sponsor or CRO setting
  • In-depth knowledge of clinical trial operations, ICH, GCP guidelines and other applicable regulatory requirements
  • Experience directing members of clinical operations teams

Responsibilities

  • Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations
  • Manage strategic engagement with key collaborators
  • Set up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets
  • Key contributor to IRB/EC and regulatory submissions

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • 188 - 188K yearly
  • English

Other skills

  • Professionalism
  • Non-Verbal Communication
  • Ethical Standards And Conduct
  • Teamwork
  • Critical Thinking
  • Creative Problem Solving
  • Self-Confidence
  • Detail Oriented
  • Intellectual Curiosity
  • Relationship Building
  • Quality Control
  • Problem Solving
  • Innovation

About the company

Praxis Precision Medicines, Inc. logo

Praxis Precision Medicines, Inc.

Biotechnology

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for rare and more prevalent neurological disorders.We share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrumโ„ข, and antisense oligonucleotide (ASO) platform, Solidusโ„ข, using our understanding of shared biological targets and circuits in the brain.

Company details

IndustryBiotechnology
Company size51 - 200

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Job description

Senior Clinical Trial Manager (CTM) 

Location:   This position may be performed remotely with travel to the Boston area as needed.   

Position Summary 

This role will be responsible for project management in the initiation, execution and close out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation. 

This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team. 

Primary Responsibilities 

  • Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations 
  • Manage strategic engagement with key collaborators 
  • Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc. 
  • Key contributor to IRB/EC and regulatory submissions 
  • Oversee TMF reviews to ensure completeness and inspection readiness 
  • Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) 
  • Identify and mitigate against study risks, escalating as necessary 
  • Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development 

Education and Professional Experience 

  • Bachelorโ€™s degree in a scientific field required; advanced scientific degree a plus 
  • 5+ years directly managing clinical trials in Sponsor or CRO setting 
  • In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements 
  • Experience directing members of clinical operations teams 
  • Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance) 

Other Essentials and Key Success Factors 

  • Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit 
  • Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve 
  • Self-motivated and able to work autonomously, as well as a member of a collaborative team 
  • Highly-organized and detail-oriented with a passion to deliver quality results 
  • Strong verbal and written communication skills with an ability to build relationships internally and externally 
  • Highest levels of professionalism, confidence, personal values and ethical standards 
Annualized Base Salary
$168,000โ€”$188,000 USD

Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MOREยฎ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

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Marcus Rivera

Chief Revenue Officer

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